A US class action suit alleges that a settlement between Teva and Novo Nordisk illegally delayed generic Victoza for 16 months, kept prices high and transferred an estimated $903m in value to Teva.
‘It’s A Great Opportunity But It’s Also Late’ – Samsung Bioepis’ Woollett On Biosimilar Streamlining
Regulatory streamlining represents a paradigm shift for the biosimilars industry, but does it go far enough? Gillian Woollett, Samsung Bioepis’ head of regulatory strategy and policy, says streamlining must be accompanied by a sustainable economic environment for biosimilars to ensure global access.
Alvotech has ticked off all of the remaining patent-related matters for its aflibercept biosimilar, with multiple market entries expected in 2026.
Teva says it has 10 additional biosimilars in development for launch from 2028 onwards, extending its portfolio beyond 2027 as it targets European growth and expands through partnerships.
Even though the ink has long dried on the US-South Korea trade deal, new threats have prompted Celltrion to reiterate its “fundamental solution” to tariff concerns.
Dr Reddy’s gears for semaglutide debut across markets, including India and Canada, where Novo Nordisk has second brands of the GLP-1 agonist potentially ready. Can the Indian group close out compliance queries from the Canadian regulator soon?
With the separation from its parent company now behind it, Samsung Bioepis celebrated its highest-ever annual revenues and outlined its vision of further growth.
MS Pharma is continuing to capitalize on opportunities for localized manufacturing in the Middle East, with its latest deal with Hetero Biopharma covering five biosimilars.
Responding to recent FDA guidance on a new streamlined pathway for US biosimilars, off-patent industry representatives have urged the agency to make the approach “the new default” for biosimilar filings. However, PhRMA has suggested limiting the route to less complex product types.
Sun Pharma’s generic Wegovy product has cleared regulatory review, positioning the company to enter India’s obesity drug market once patent protection lapses.
In line with previously disclosed launch and partnering plans for GLP-1 products, Lupin shook hands with Galenicum, securing commercial rights to injectable semaglutide.
As Dr Reddy’s delivered results for its financial third quarter, the firm revealed a slew of updates for key biosimilars in its pipeline including filing and launch plans for abatacept in the US and Europe, as well as US setbacks on rituximab and denosumab.
BMS will continue to seek legal recourse even as Zydus Lifesciences launches the world’s first cut-price nivolumab biosimilar in India following a Delhi High Court division bench ruling in favor of the Indian company.
Generics Bulletin reviews global regulatory developments across the world.
Hyloris and Orion continue to build on their partnership with another value-added medicine collaboration in Europe.
Amarin has hit back over the US Supreme Court’s decision to review skinny-label induced infringement litigation with Hikma over Vascepa (icosapent ethyl).
Hikma has launched its Enoby and Xtrenbo denosumab biosimilars to Amgen’s Prolia and Xgeva into the competitive US market. How will the firm fare against so many other rivals?
Biocon Biologics has become one of the most prominent global biosimilars firms since its buyout of former partner Viatris’ biosimilars business. With a rumored IPO instead making way for a merger with generics unit Biocon Ltd, the business’s chief Shreehas Tambe sets out the reasons for the move.
A joint pilot between Phlow and AI biotech Enveda suggests high-quality data and deep learning could cut Phlow’s active pharmaceutical ingredient development from years to months.
Sun terms reports of acquisitive interest in Organon as "speculative," at least for now. Bankers see a potential transaction fit the profile of a 'typical’ Sun deal, which if it occurs also catapults the Indian firm’s foray into biosimilars.